# K140020: Hyperq Acs-100 System

- Pathway: 510(k) (Traditional)
- Applicant: Bsp-Biiological Signal Processing, Ltd.
- Decided: Oct 28, 2014 after 298 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K903644 (1991). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090212: Mac 800 Resting Ecg Analysis System, Ge Medical Syst. Information Technologies (2009) Summary page 4.
- K102579: Hyperq AD-100 System, Biological Signal Processing, Ltd. (2010) Summary page 4.

## Indications for use
The BSP HyperQ™ Rest System is intended to be used during rest ECG tests, using the analysis of high frequency components present within the central portion of the QRS complex (HF-QRS). The device outputs a reduced amplitude zone (RAZ) value for the physician to interpret (based on reported clinical study results). The device is indicated for use in the ECG interpretation of patients with acute chest pain presenting to the Emergency Department, aged 18 years and above, as an additional adjunctive aid during initial patient presentation. The significance of the HF-QRS changes and interpretation of the HyperQ™ Rest analysis must be determined by a physician, based on the reported clinical study results presented in the device labeling.

Source page: https://510kreport.com/device/K140020
Methodology: https://510kreport.com/methodology